| Device Classification Name |
Stand, Instrument, Ophthalmic, Non-Powered
|
| 510(k) Number |
K873554 |
| Device Name |
GORSK INSTRUMENT REST |
| Applicant |
| Gorsk, Inc. |
| P.O. Box 398 |
|
Camarillo,
CA
93011
|
|
| Applicant Contact |
NANCY G GORSKI |
| Correspondent |
| Gorsk, Inc. |
| P.O. Box 398 |
|
Camarillo,
CA
93011
|
|
| Correspondent Contact |
NANCY G GORSKI |
| Regulation Number | 886.1860 |
| Classification Product Code |
|
| Date Received | 08/28/1987 |
| Decision Date | 10/23/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Ophthalmic
|
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|